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Completed NCT07335198

A Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Immunogenicity of Efimosfermin Alfa Administered as a Single Dose to Healthy Participants of Chinese, Japanese, and White/European Ancestry

Conditions: Non-alcoholic Fatty Liver Disease

Sex: All
Ages: 18 Years – 55 Years
Healthy volunteers: Yes
Phase: PHASE1
Enrollment: 30
Sponsor: GlaxoSmithKline

Location: GSK Investigational Site Auckland

Summary

This is a first time in Asia (FTIA) study designed to evaluate the safety, tolerability, pharmacokinetic (PK) and immunogenicity of efimosfermin alfa to healthy participants of Chinese, Japanese, and White/European ancestry.

Eligibility Criteria

Inclusion Criteria: Participants who are generally healthy as determined by medical evaluation * Body weight at least 50.0 kilograms (kg) for male participants or at least 45.0 kg for female participants * Body mass index (BMI) within the range of 18.0 to 28.0 kilograms per square meter (kg/m\^2) (inclusive) * Male and female participants * Participants of Chinese ancestry are eligible if born in mainland China, Hong Kong, or Taiwan, and descendant of 2 ethnic Chinese parents and 4 ethnic Chinese grandparents; and have lived outside China, Hong Kong, or Taiwan for less than 10 years at the time of screening. * Participants of Japanese ancestry are eligible if born in Japan and descendant of 2 ethnic Japanese parents and 4 ethnic Japanese grandparents; and have lived outside Japan for less than 10 years at the time of screening. * Participants of White/European ancestry are eligible if self-identified as being of White/European ancestry, (that is \[i.e.\], from the original peoples of Europe) irrespective of current place of residence; and descendant of 2 parents and 4 grandparents of White/European ancestry (i.e., from the original peoples of Europe) irrespective of place of birth or current place of residence. Exclusion Criteria: * History or presence of disorders capable of significantly altering the absorption, metabolism, or elimination of drugs; constituting a risk when taking the study intervention or interfering with the interpretation of data. * Current or chronic history of liver or biliary disease with the exception of Gilbert's syndrome or asymptomatic gallstones. * History of pancreatic injury, pancreatitis or other pancreatic disease; history of Type one Diabetes Mellitus (T1DM) or positive glutamic acid decarboxylase auto-antibodies, or major Type two Diabetes Mellitus (T2DM) complications including severe gastroparesis and autonomic neuropathy. * Abnormal blood pressure (defined as systolic Blood Pressure \[BP\] more than equal \[\>=\]140 millimeters of mercury \[mmHg\] or diastolic BP \>=90 mmHg measured based on the average of triplicate BP readings). * History of metabolic bone disorders including osteoporosis, osteopenia, or osteomalacia. * History of malignancy of any organ system (other than localized basal cell carcinoma of the skin), treated or untreated, within the past 5 years. * Alanine transaminase (ALT) more than (\>)1.5 \* upper limit of normal (ULN). * Total bilirubin \>1.5 \* ULN * Known bleeding disorder. * History of immunodeficiency diseases, including a positive test result for human immunodeficiency virus (HIV). * Corrected QT Interval using Fridericia's Formula (QTcF) \>=450 millisecond (msec)(male) or \>=470 msec (female) at Screening Visit based on the average of triplicate ECGs. * Use of statins, other lipid lowering medications or hypertension medications unless on a stable dose for at least 3 months. * Use of other investigational drugs at the time of enrollment, or within 5 half-lives of enrollment, or within 30 days, whichever was longer; or longer if required by local regulations. * Participants who have received native FGF21 or a FGF21 analog at any time in the past. * Intended use of over the counter (OTC) or prescription medication (including herbal medications) within 7 days prior to dosing and for the duration of study participation. * Live vaccine within 14 days prior to dosing and non-live vaccines for 7 days prior study dosing. * Current enrolment or participation in another clinical trial within the last 30 days before signing consent of current study. * Presence of hepatitis B surface antigen (HBsAg) or hepatitis C antibody at screening or within 3 months prior to the first dose of study intervention * A positive pre-study drug/alcohol screen

Interested in this study? View the official listing for contact and enrollment details.

View on ClinicalTrials.gov

Source: ClinicalTrials.gov (NCT07335198). StuddyBuddy aggregates publicly available trial information.